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When President Joe Biden took office this month, increasing the available supply of COVID-19 vaccines became a top priority for his administration.
The Biden administration’s mission: To find a way to produce even more doses of the vaccine at a faster rate, exceeding the quantity and schedule promised by pharmaceutical companies Pfizer and Moderna under their contracts with the US government.
But experts say it won’t be that easy. A vaccine is not a piece of steel, it is a complex biomedical product.
“We’re actually dealing with living organisms here,” said Cody Powers, principal at ZS Associates, a professional services firm that works with companies to help develop and deliver medical products. It’s “different from making simple consumer goods that you can maybe assemble a production line faster.”
Pfizer and Moderna both use a new vaccine technology: messenger RNA or mRNA. RNA is particularly fragile, so it is essential for drug manufacturers to manage the process scrupulously and meticulously to maintain their quality control and ensure safety.
“To actually produce what’s in the vaccine, whether it’s a reagent, an antigen, or in the case of Pfizer and Moderna, mRNA, you have to produce that part of it,” then you have to harvest it, and then you have to produce the encapsulation, ”said Dr. Bruce Y. Lee, executive director of research in informatics, informatics and public health operations and professor of policy and management in health at the City University of New York.
Each of these steps requires specific equipment, as well as the right staff to do it, he said, adding: “You can’t always necessarily prevent a person from doing one aspect of a product line by changing them. . “
There are also elaborate procedures to be followed to ensure that all manufacturing requirements and safety protocols have been followed, and factories are subject to regular audits by the Food and Drug Administration. And the consequence of sending a spoiled batch to be injected into people’s arms would be catastrophic, experts warned.
“A lot of time, energy, attention and resources are required to ensure that the process meets all the requirements for being able to produce responsibly,” Powers noted, saying public confidence in vaccines is fragile.
Meanwhile, there is also a learning curve, experts said. This is the first time that this type of vaccine has been manufactured on such a commercial scale. So “we don’t know everything there is to know yet” about these new vaccines and technologies, Powers added.
Pfizer CEO Albert Bourla said in an interview with Bloomberg on Tuesday that the company would be able to deliver 200 million doses of COVID-19 vaccine to the United States by the end of May, two months ahead of schedule. .
Moderna CEO Stéphane Bancel also told a Nasdaq investor conference last month that he felt “very comfortable” that the company was able to produce 500 million doses of its vaccine. COVID-19 in 2021.
Johnson & Johnson, which is expected to apply for emergency use authorization in the coming weeks, said on Tuesday it was on track to deliver 100 million doses of the coronavirus vaccine to the United States by the next end of June.
But even if factories owned by Pfizer and Moderna – the only two vaccines currently licensed in the United States – are operating at maximum capacity, there may be other ways to increase supply, experts said. A third company could volunteer and provide a factory with the right equipment to do the job.
An example of such a collaboration is that of the agreement of the French drug manufacturer Sanofi with its rivals, Pfizer and BioNTech, to produce more than 100 million doses of their mRNA vaccine for the European Union at the Sanofi site. in Frankfurt, Germany.
This unusual pact could encourage other pharmaceutical companies to cooperate with companies developing effective vaccines, Lee said.
But factories with this level of technical capacity are rare and they should stop making other life-saving drugs to prioritize mRNA vaccines.
Vaccine makers rarely devote everything to a single product, Lee explained. “They also produce products that generate income for them,” Lee said.
Still, experts said there may be other, smaller ways for the Biden administration to help boost manufacturing supply. The administration should assess the entire vaccine supply chain as quickly as possible, to see where the vaccines are really stuck, Lee said.
“You don’t just run around the football field without planning and really seeing what the situation is first. If you are trying to adapt on the fly, you might not know the deeper problem,” he said. he declared.
In its first week, the administration quickly focused on a key issue: syringes. The FDA has allowed medical staff to extract additional doses from Pfizer vials, but to use the full available supply of these vials more precise and specialized syringes are needed.
More people can be vaccinated if we make better use of the supply that’s already being made, Powers said.
White House press secretary Jen Psaki discussed at her first briefing using the Defense Production Act, a Cold War-era law that gives the government some control over private industry, to manufacture these syringes, but the Biden administration was not specific on them might be doing this.
Meanwhile, the administration could help companies secure much-needed raw materials and chemical ingredients – an ongoing challenge, especially as the pandemic is a global crisis, with many countries competing for the same supplies.
“It’s a global economy and we don’t have the capacity to provide everything we need on our shores,” said Erin Fox, senior director of drug information and support services at the University. of Utah Health. Securing more raw ingredients could become a key diplomatic goal for the Biden administration.
But at the end of the day, only the companies themselves can say exactly what would help boost supply. And the pharmaceutical industry is well guarded, Fox said.
“In fact, we don’t know if we just need to trust companies to tell us what they might need because they don’t have any obligation to be transparent,” Fox said.
As of Friday, 49.2 million doses of the vaccine had been distributed by the federal government to states and other jurisdictions, according to the Centers for Disease Control and Prevention. Of this amount, 27.8 million doses – approximately 56.7% – were administered.
Moderna and Pfizer have agreed to provide the federal government with 200 million doses by the summer, enough for 100 million Americans. Johnson & Johnson, which is expected to apply for emergency use authorization in the coming weeks, said on Tuesday it was on track to deliver 100 million doses of the coronavirus vaccine to the United States by the next end of June.
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